Director, Decentralized Clinical Trials RWE Clinical Trials – Remote Work Opportunity at blithequark

Are you a seasoned professional with a passion for decentralized clinical trials and a knack for leading cross-functional teams? Do you thrive in a fast-paced environment where innovation and adaptability are key? If so, we invite you to join blithequark as a Director, Decentralized Clinical Trials RWE Clinical Trials. In this pivotal role, you will play a crucial part in shaping the future of clinical trials and driving the growth of blithequark's Decentralized Clinical Trials (DCT) business.

About blithequark

blithequark is a leading healthcare company that is revolutionizing the way clinical trials are conducted. With a strong commitment to innovation and patient-centricity, we are dedicated to delivering high-quality, decentralized clinical trials that meet the evolving needs of our clients and patients. Our team of experts is passionate about making a meaningful impact in the healthcare industry, and we are seeking like-minded individuals to join our mission.

Job Summary

As a Director, Decentralized Clinical Trials RWE Clinical Trials, you will be responsible for leading the development and execution of clinical trials, including direct trials on time, on budget, in compliance, and of superior quality. You will work closely with the Head of Decentralized Clinical Trials to develop and implement blithequark's DCT services, building and delivering adaptable, efficient, and patient-friendly hybrid and decentralized trials.

Key Responsibilities

* Develop and execute clinical trials, including direct trials on time, on budget, in compliance, and of superior quality

• Manage cross-functional review teams during all phases of study development, operationalization, and delivery
• Collaborate with the Head of Decentralized Clinical Trials to develop and implement business strategies, resource allocation, and operational plans for decentralized and hybrid trials
• Administer the selection and management of decentralized trial vendors, including the development of business requirements and UAT process management
• Oversee cross-functional colleagues in the development of study protocols and plans, including but not limited to: convention, ICF, SAP, DMP, and Security plan development
• Select, train, manage, and coach DCT colleagues; Collaborate with Product and Innovation initiatives to ensure that key features for customers are launched on time and meet customer needs
• Provide oversight to the lead of remote clinical trial visits, site initiations, and study closures with client representatives
• Participate in business development efforts, including proposal and budget development, and bid defense process
• Assist in the development and maintenance of relevant SOPs, plans, and procedures related to DCTs
• Contribute to the technical team to extend capabilities to support customer needs

Essential Capabilities

* Past experience or CRO experience creating and driving DCT projects, including budget and scope development

• Knowledge of and experience managing DCT vendors
• Deep understanding of the drug development process, including decentralized and hybrid trials
• Strong working knowledge of ICH GCP, US CFR, and HIPAA regulations
• Educated with the skills and ability to apply new frameworks to routine tasks
• Understand the importance of adaptability and willingness to learn and adjust to technology changes over time
• Strong leadership skills with demonstrated ability to lead internal and external teams
• Ability to work independently and make timely, critical decisions to operationalize and move clinical trial projects forward
• Ability to manage multiple tasks simultaneously, while maintaining attention to detail
• Ability to focus on tasks and resources, comply with time constraints, and be flexible to changing needs
• Excellent written and oral communication and presentation skills
• Willingness to travel up to 20% of the ideal time for business purposes within state and out of state

What We Offer

* Competitive salary range: $20-30/hour

• Opportunity to work with a leading healthcare company that is revolutionizing the way clinical trials are conducted
• Collaborative and dynamic work environment with a team of experts passionate about making a meaningful impact in the healthcare industry
• Professional development opportunities to enhance your skills and knowledge
• Flexible work arrangements, including remote work options
• Comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off

How to Apply

If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity. Please submit your resume and a cover letter outlining your qualifications and experience. We look forward to hearing from you! Apply Now! Apply for this job